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Effect of Longitudinal Sleep Monitoring on Diagnosis and Treatment Decision in Patients With Suspected Obstructive Sleep Apnea (ELSA)

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ClinicalTrials.gov Identifier: NCT03819361
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Malcolm Kohler, University of Zurich

Brief Summary:

Obstructive sleep apnea (OSA) is a highly prevalent sleep-disordered breathing disease, caused by recurrent episodes of partial or complete collapse of the upper airway during sleep, resulting in intermittent hypoxia, fragmented sleep, fluctuations in blood pressure, and increased sympathetic nervous system activity. A single-night sleep study (i.e. respiratory polygraphy or polysomnography) is currently considered to be the gold standard for diagnosing OSA. However, recent studies suggest a significant intra-individual night-to-night variability of respiratory events, leading to the hypothesis that one single-night study might not reflect an accurate picture of the disease.

Part A: Patients with suspected obstructive sleep apnea, referred to our clinic, undergo the regular diagnostic procedure recommended by the current guidelines. In addition to the in-hospital single-night sleep study, these patients will perform 14 nights of pulse-oximetry at home. By computing and analysing sensitivity and specificity of every additional night, the investigator will answer the questions how many nights of sleep monitoring by home oximetry are necessary to diagnose OSA reliably, and how longitudinal sleep monitoring could reduce the number of false-negative and false- positive results compared to the in-hospital single-night study.

Part B: Based on the patients' data of part A, the investigator will develop a questionnaire and present anonymized cases to experts in the field of sleep medicine. Thereby, the investigator will evaluate if the additional information of repeated nocturnal pulse-oximetries changes the experts' decision making regarding diagnosis and treatment of OSA.

In a second step, the investigator will perform a classical Delphi study with a panel of experts in sleep medicine to establish consensus on repeated sleep studies and how they should be used for diagnosis and treatment in patients with suspected OSA.


Condition or disease Intervention/treatment
Obstructive Sleep Apnea Diagnostic Test: pulse-oximetry

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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Longitudinal Sleep Monitoring on Diagnosis and Treatment Decision in Patients With Suspected Obstructive Sleep Apnea (ELSA)
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Group/Cohort Intervention/treatment
Suspected OSA Diagnostic Test: pulse-oximetry
Patients with suspected OSA will be monitored with 14 nights of pulse-oximetry prior to the already planned in-hospital single-night sleep study at the University Hospital Zurich




Primary Outcome Measures :
  1. The accuracy of 1-13 nights of pulse-oximetry compared to the mean ODI of 14 consecutive nights [ Time Frame: 14 nights of pulse-oximetry ]
    "Sensitivity" and "specificity" for every additional night will be assessed

  2. Decision making of a panel of experts in the field of sleep medicine regarding diagnosis and severity of OSA (no OSA, mild, moderate, severe) with/without the additional information of longitudinal sleep monitoring [ Time Frame: 14 nights of pulse-oximetry ]

Secondary Outcome Measures :
  1. ODI variability measured in 14 consecutive nights of pulse-oximetry [ Time Frame: 14 nights of pulse-oximetry ]
  2. Change of OSA severity class (no OSA, mild, moderate, severe OSA) during 14 nights of pulse-oximetry due to ODI variability [ Time Frame: 14 nights of pulse-oximetry ]
  3. Change of OSA severity class (no OSA, mild, moderate, severe OSA) diagnosed by in-hospital single-night sleep study vs repeated measurements by pulse-oximetry [ Time Frame: 14 nights of pulse-oximetry ]
  4. Decision making of a panel of experts in field of sleep medicine regarding treatment decisions (CPAP yes/no) with/without the additional information of longitudinal sleep monitoring [ Time Frame: 14 nights of pulse-oximetry ]
  5. Establish consensus on repeated sleep studies and their use in diagnosis and treatment in patients with suspected OSA [ Time Frame: 14 nights of pulse-oximetry ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with suspected obstructive sleep apnea
Criteria

Inclusion Criteria:

  • Informed consent
  • Suspected obstructive sleep apnea
  • ≥18 years old

Exclusion Criteria:

  • Suspected or diagnosed sleeping-disordered breathing other than OSA
  • Moribund or severe disease prohibiting protocol adherence especially COPD GOLD III-IV and heart failure NYHA III-IV
  • Patients receiving oxygen therapy or home ventilation
  • Continuous positive airway pressure treatment for OSA at baseline
  • Physical or intellectual impairment precluding informed consent or protocol adherence
  • Pregnant patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03819361


Contacts
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Contact: Malcolm Kohler, Prof. Dr. med. +41 44 255 38 28 malcolm.kohler@usz.ch
Contact: Maurice Roeder, Dr. med. +41 44 255 4801 maurice.roeder@usz.ch

Locations
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Switzerland
University Hospital Zurich Recruiting
Zürich, Zurich, Switzerland, 8091
Contact: Maurice Roeder, MD    +41442554801    malcolm.kohler@usz.ch   
Sponsors and Collaborators
Malcolm Kohler
Investigators
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Principal Investigator: Malcolm Kohler, Prof. Dr. med. University of Zurich

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Responsible Party: Malcolm Kohler, Head of the department of pulmonology, University of Zurich
ClinicalTrials.gov Identifier: NCT03819361     History of Changes
Other Study ID Numbers: 2018-02305
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Malcolm Kohler, University of Zurich:
Night-to-night variability
Apnoea-Hypopnoea Index
Oxygen Desaturation Index
Pulse-oximetry
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases